According to the FDA, Abiomed told customers to remove certain Impella CP systems from use or sale. This action impacts serial numbers 613525, 644314, 645428, 644591, 672986, 673252 and 677223, according to the FDA.
Abiomed, the J&J Heart Recovery unit, said that specific units of Impella CP with SmartAssist do not meet design specifications. This out-of-specification may result in low purge pressure events from the onset of the case.
Exposure to low purge pressure may result in persistent low purge pressure alarms. In some cases, this can lead to the interruption or loss of mechanical circulatory support. Loss of support may lead to an acute change in care during pump exchange, hypotension, end-organ hypoperfusion and risk of death if not promptly corrected.
As of May 7, Abiomed reports three pump exchanges, which can potentially result in serious injuries, and one death associated with the issue.
Impella CP with SmartAssist provides temporary ventricular support during elective or urgent high-risk percutaneous coronary interventions (PCI) performed in hemodynamically stable patients with severe coronary artery disease (CAD).
Abiomed recommends that customers review all Impella CP sets within inventory and quarantine affected product. They should return all affected product as well.
Statement from J&J
A spokesperson for Johnson & Johnson shared the following statement with MassDevice via email:
At Johnson & Johnson, patient safety is our top priority, which is why we have initiated a voluntary device recall of seven (7) specific Impella CP Sets with SmartAssist in the U.S. An internal review found that these seven units do not meet design specifications, leading to the potential for low purge pressure events.
We are notifying impacted customers and working to issue a credit.
The latest warning for J&J, Abiomed and Impella
Abiomed, which J&J acquired for $16.6 billion in 2022, has faced a handful of regulatory issues related to the Impella platform in recent years.
Last fall, Abiomed reported five serious injuries and no deaths associated with an issue with AIC purge pressure, leading to purge retainer failures, such as cracks. That warning came not long after different FDA communications related to the Impella pump controllers. In July 2025, the FDA alerted providers that Abiomed issued updated instructions for use related to all of its AICs. As of June 13, Abiomed had reported no serious injuries and 3 deaths associated with that issue.
In August 2025, the FDA issued another alert for Abiomed instructing customers to remove certain AICs from use or sale. According to an Abiomed spokesperson, the issue affected 69 AICs globally. As of Aug. 12, 2025, Abiomed reported one death and no serious injuries associated with that issue.
In February, the FDA said Abiomed issued an urgent medical device correction to notify affected customers of updated use instructions for all Impella RP with Smart Assist and Impella RP Flex with Smart Assist devices. Later that month, it issued a warning related to Impella purge cassettes.
Then, earlier this month, the company initiated a voluntary recall for Impella AICs after identifying a potential software issue in a limited number of AICs when used with left ventricular Impella devices.
